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Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition.
For manufacturers reporting adverse incidents with neurostimulators under the vigilance system.
Report on the service providing sterile, controlled environments for the preparation of injectable medicines into ready-to-administer formats for patients.
Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
The pre-clinical evaluation team at VDEC provides a safe and controlled environment to test new vaccines and therapeutics before they progress to clinical trials
Canada and UK Trade Continuity Agreement enters into force
Guidance for specialists for initiation of valproate in female patients and for annual review and pregnancy testing to support adherence to pregnancy prevention requirements during the pandemic.
This guidance is designed to provide information on the implementation of changes to advertising and promotion of medicines authorised in the UK from 1 January 2025.
Acceptable naming, presentation and packaging of nicotine-containing electronic cigarettes and refill containers.
Under some circumstances (clarified in this statement), the CMA will not prioritise enforcement action against competing drug firms in relation to commercial negotiations to make combination therapies available to patients, …
Scientific advice queries on nanomedicines have increased in recent years, particularly on lipid nanoparticles.
How to apply to have nutritional or dermatological products reviewed by the Advisory Committee on Borderline Substances (ACBS).
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
How to best protect patients and volunteers during magnetic resonance imaging (MRI) examinations.
Outlines the aim, scope and definitions of the medical technology innovation classification framework.
Instructions for integrating with the new production MORE platform API.
Notification Fees for Great Britain and Northern Ireland
Poster with advice for healthcare professionals on how to carry out point of care testing safely and correctly.
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